Targeting Cerebrovascular Reactivity for Precision Medicine: Pilot Trial of Atorvastatin
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change of MRI whole brain cerebrovascular reactivity (wbCVR)
研究概览
简要总结
The purpose of this study is to evaluate the effect of atorvastatin on brain vessel reactivity and with it on blood flow in people with mild cognitive impairment.
详细描述
Participants are first being informed about potential benefits and risks of the study and are required to give written consent. After that participants will undergo detailed phone screen to determine eligibility for study entry. At week 0, participants who meet eligibility requirements will be prescribed atorvastatin (40 mg, once in the evening) in an open-label manner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •are chosen to include participants with MCI, enriched for vascular risk factors:
- •MCI defined by Clinical Dementia Rating (CDR) of 0.5 or 1.
- •Memory, processing speed, executive function, language - cognitive scores > 1.5 standard deviations below age-education norms.
- •Not demented by history.
- •Not taking statins currently or in the last 6 months.
- •Cognitive/functional impairment not likely due to another neurological disease or delirium.
排除标准
- •Taking a statin currently or have taken a statin in the last 6 months.
- •Contraindications to taking a statin.
- •Transplant patient taking cyclosporine.
- •Unable to undergo MRI procedures (such as having an implanted pacemaker or defibrillator or stimulator or having non MRI compatible metal).
- •Diagnosis of dementia by history.
- •Current diagnosis of substance abuse.
- •History of stroke or myocardial infarction in past 6 months.
- •History of HIV.
研究组 & 干预措施
Atorvastatin 40 mg
Participants receive 40 mg atorvastatin orally daily in the evening.
干预措施: Atorvastatin Oral Tablet (Drug)
结局指标
主要结局
Change of MRI whole brain cerebrovascular reactivity (wbCVR)
时间窗: Baseline and 12 weeks
MRI based CVR is a newer technique that measures dilatory function of the microvessels which have been shown to be superior to measurement of Cerebral blood flow (CBF) and have also been shown to be low in participants with MCI.
次要结局
- Change in cognitive function (global neurocognitive measure)(Baseline and 12 weeks)
- Change in plasma exosomes(Baseline and 12 weeks)
- Change in cognitive function (domain-specific neurocognitive measure)(Baseline and 12 weeks)